A Pivotal Study to Assess the Safety and Efficacy of The PrePex System, a Male Circumcision Device and Methodology for Rapid Scale up of Painless and Bloodless National Circumcision Programs, in Urban and Remote Rural Settings

• The efficacy and safety of The PrePex System for adult male circumcision in Rwanda [ Time Frame: 4 week post-procedure follow up appointment and examination ] [ Designated as safety issue: Yes ]

  Outcome measures will include:

  Number of Participants with Adverse Events as a Measure of Safety,

  Pain as measured by Visual Analogue Scale (VAS),

  Wound healing rate.

  
  

• Operational scalability to mass scale up program [ Time Frame: four week post-procedure follow up appointment and examination ] [ Designated as safety issue: No ]

  Outome measure include:

  Duration required by diffrent personnel to perform the procedure Procedure performance by nurses

  
  
• satisfaction & acceptability of patients [ Time Frame: 4 weeks follow up ] [ Designated as safety issue: No ]

  Outcome measure include:

  Quality of life and satisfaction questionnaire

  
  
• Guidelines for utility in scale up mass circumcision program [ Time Frame: 4 weeks follow up ] [ Designated as safety issue: No ]

  Outcome measure includes:

  Physicians questionnaire on the clinical and practical performance of the procedure

  
  
• compliance with post procedure instructions [ Time Frame: 4 weeks follow up ] [ Designated as safety issue: No ]

  Outcome measure include:

  Weekly follow up visits post procedure, compliance with post procedure instructions questionnaire

  
  

Multiple randomized and controlled studies (WHO, USAID, UNAIDS) have proven that circumcised men in high risk areas reduce their risk of HIV infection by 60%.

The Government of Rwanda has ranked HIV prevention as a top priority item, and wishes to decrease the HIV incidence in the country by 50%. As part of a holistic HIV prevention approach, we decided to embark upon a process of national scale up of adult male circumcision. The national HIV prevention plan calls for voluntary MC of 2 million adults by the end of 2012.

The PrePex System was designed to enable safe, effective, painless and bloodless male circumcision programs, to support global public health efforts to stop the spread of HIV.

The PrePex System includes a simple, disposable device that is easy to use and can be deployed by minimally trained healthcare professionals, in urban or rural settings, without the need for sterile, hospital settings. As such, The PrePex System places minimal burden on the existing health care infrastructure to accomplish national circumcision programs.

The protocol, approved by the Rwanda National Ethical Committee, was issued to assess the safety and efficacy of the circumcision device for applying it to the national scale up of adult male circumcision in Rwanda.